Nupralgin Plus 500

✔️ Nupralgin Plus should not be used in patients with:

• Hypersensitivity to naproxen, esomeprazole, substituted benzimidazoles, or any formulation component
• History of asthma, urticaria, or allergic reactions triggered by aspirin or other NSAIDs
• Patients undergoing coronary artery bypass graft (CABG) surgery during the perioperative period

✔️ Renal Impairment

• Not recommended in patients with moderate to severe renal dysfunction (creatinine clearance <30 mL/min).

✔️ Elderly Patients

• Increased susceptibility to adverse effects, particularly gastrointestinal bleeding and ulceration.
• Use the lowest effective dose and monitor closely.

✔️ Hepatic Impairment

• Mild to moderate impairment: monitor carefully and consider dose adjustment.
• Severe hepatic impairment: use is not recommended.

✔️ Drug Interactions

With Medicines

• May reduce the antihypertensive effects of ACE inhibitors, beta-blockers, and diuretics.
• Concomitant use with warfarin may increase bleeding risk.
• Esomeprazole may affect the absorption of drugs whose bioavailability depends on stomach acidity, such as ketoconazole, iron supplements, and digoxin.

With Food

• High-fat meals do not significantly affect naproxen absorption but may delay its absorption and reduce peak plasma concentrations.

✔️ Overdose & Management of Nupralgin Plus

Naproxen Overdose

Symptoms may include:

• Drowsiness
• Dizziness
• Nausea and vomiting
• Abdominal discomfort
• Metabolic acidosis
• Renal dysfunction
• Respiratory depression
• Coma (rare)

Esomeprazole Overdose

Reported symptoms are generally mild and temporary.

Management

• Symptomatic and supportive treatment
• Activated charcoal may be considered if ingestion is recent
• Hemodialysis is ineffective for naproxen due to extensive protein binding
• No specific antidote is available

✔️ The esomeprazole component helps lower the incidence of gastrointestinal complications associated with naproxen.

Common adverse effects may include:

• Nausea
• Vomiting
• Diarrhea
• Dyspepsia
• Abdominal pain
• Constipation
• Flatulence

Serious adverse effects may include:

• Peptic ulceration
• Gastrointestinal bleeding or perforation
• Fluid retention and edema
• Hypertension
• Heart failure
• Increased risk of cardiovascular thrombotic events such as heart attack or stroke
• Exacerbation of ulcerative colitis or Crohn’s disease

✔️ Pregnancy & Lactation

Pregnancy

• Use during the first and second trimesters only if the expected benefit outweighs potential risks.
• Contraindicated during the third trimester of pregnancy.

Breastfeeding

• Naproxen is excreted in breast milk in small amounts.
• Use during breastfeeding is not recommended.

Fertility

• NSAIDs may impair female fertility; therefore, use is not advised in women attempting to conceive.

✔️ Precautions & Warnings

General Precautions

• Avoid concurrent use with other NSAIDs, including selective COX-2 inhibitors.
• Use the lowest effective dose for the shortest possible duration.
• Long-term users should undergo regular medical monitoring.

Gastrointestinal Precautions

Patients with:

• Previous peptic ulcer disease
• History of gastrointestinal bleeding
• Helicobacter pylori infection
• Advanced age
• Concurrent use of corticosteroids, anticoagulants, SSRIs, or low-dose aspirin

require close monitoring due to an increased risk of GI complications.

Cardiovascular Precautions

Use cautiously in patients with:

• Hypertension
• Congestive heart failure
• Ischemic heart disease
• Peripheral vascular disease
• Cerebrovascular disease

Renal Precautions

Long-term NSAID therapy may lead to renal impairment, including renal papillary necrosis and other forms of kidney injury.

Esomeprazole-Related Precautions

Long-term treatment may:

• Increase the risk of gastrointestinal infections (e.g., Salmonella, Campylobacter)
• Reduce vitamin B12 absorption, potentially leading to deficiency

✔️ Storage:

Store below 30°C in a dry place, protected from light and moisture. Keep out of the reach of children.